Avapro

[Irbesartan]

The incidence of hypotension or orthostatic hypotension was low in irbesartan treated patients (0.4%), unrelated to dosage, and similar to the incidence among placebo treated patients (0.2%). Dizziness, syncope, and vertigo were reported with equal or less frequency in patients receiving irbesartan compared with placebo.

In addition, the following potentially important events occurred in less than 1% of the 1965 patients and at least 5 patients (0.3%) receiving irbesartan in clinical studies, and those less frequent, clinically significant events (listed by body system). It cannot be determined whether these events were causally related to irbesartan:

Body as a Whole:

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fever, chills, facial edema, upper extremity edema;

Cardiovascular:

flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, arrhythmic/conduction disorder, cardio-respiratory arrest, heart failure, hypertensive crisis;

Dermatologic:

pruritus, dermatitis, ecchymosis, erythema face, urticaria;

Endocrine/Metabolic/Electrolyte Imbalances:

sexual dysfunction, libido change, gout;

Gastrointestinal:

constipation, oral lesion, gastroenteritis, flatulence, abdominal distention;

Musculoskeletal/Connective Tissue: extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness;

Nervous System:

sleep disturbance, numbness, somnolence, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident;

Renal/Genitourinary:

abnormal urination, prostate disorder;

Respiratory:

epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing;

Special Senses:

vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis, other eye disturbance, eyelid abnormality, ear abnormality.

Nephropathy in Type 2 Diabetic Patients

In clinical studies in patients with hypertension and type 2 diabetic renal disease, the adverse drug experiences were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms (dizziness, orthostatic dizziness, and orthostatic hypotension) observed in IDNT (proteinuria >900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL). In this trial, orthostatic symptoms occurred more frequently in the AVAPRO group (dizziness 10.2%, orthostatic dizziness 5.4%, orthostatic hypotension 5.4%) than in the placebo group (dizziness 6.0% orthostatic dizziness 2.7%, orthostatic hypotension 3.2%).

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